Model Number 0673 |
Device Problems
Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
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Patient Problems
Device Overstimulation of Tissue (1991); Twiddlers Syndrome (4563)
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Event Date 08/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from the review, a supplemental report will be filed.
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Event Description
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It was reported that the patient with this right ventricular lead exhibited twiddlers syndrome and this lead got bent and dislodged as confirmed through x-ray.It was also noted that the patient experienced muscle stimulation.This lead was explanted and successfully replaced.This lead was returned for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
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Event Description
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It was reported that the patient with this right ventricular lead exhibited twiddlers syndrome and this lead got bent and dislodged as confirmed through x-ray.It was also noted that the patient experienced muscle stimulation.This lead was explanted and successfully replaced.This lead was returned for analysis.No additional adverse patient effects were reported.The device was returned and analyzed.
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Search Alerts/Recalls
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